CELLTRION-HEALTHCARE

Celltrion Healthcare: UK Lags behind Most of Europe in Access to Biologics for Patients with Rheumatoid Arthritis

Celltrion Healthcare calls for the NHS to consider lowering the
threshold for starting biologics in patients with rheumatoid arthritis
(RA) and to put plans in place to increase patient access to biological
treatment.

According to recent findings published in the Annals of the Rheumatic
Diseases, disease activity and the use of biological disease-modifying
anti-rheumatic drugs among patients with RA vary from country to
country, due to different contributing factors, such as per capita GDP,
drug affordability and reimbursement policies.1

There are set thresholds in disease activity before biologics can be
used in RA patients, but these thresholds vary across Europe. The
percentage of patients who are treated with an anti-TNF-α (an effective
class of treatment that reduces inflammation and pain) is 24% or higher
in countries such as Italy and France, however, in the UK this drops to
just 15%. This is because in the UK a patient must have a higher DAS-28
(a measure of how severe the disease is) threshold of 5.1 compared to
only 3.2 in other European countries. 2,3,4
Despite the
National Institute for Health and Care Excellence (NICE) widely
acknowledging that appropriate biological treatments are clinically
effective for all subgroups of RA patients, access to these therapies
remains restricted in UK on grounds of cost-effectiveness.5

Speaking at the Health and Care Innovation Expo 2018 taking place on 5
and 6 September, Dr. Ben Parker, Consultant Rheumatologist, Manchester
University Hospitals, NHS Foundation Trust says, “A UK patient’s burden
of disease must be much more severe before they qualify for biologic
therapy, compared to a French patient. As a treating physician, I
strongly believe that this inequality needs to be addressed so that our
patients can realize the same benefits of early treatment as their
European neighbors.”

The National Rheumatoid Arthritis Society (NRAS) and British Society for
Rheumatology (BSR) concur that in the UK “eligibility criteria (DAS-28
of more than 5.1) are set too high.” and state, within their
“Biologics…The Story So Far” publication, that “The BSR and others,
including NRAS, will continue to make the case to NICE for reducing the
required DAS-28 score from 5.1”.6

According to NHS’s recent savings data, NHS England saved £324m in the
last financial year by switching from using 10 higher priced medicines
to better value biosimilars and generic medicines which are considered
to be equally effective and safe alternatives. Switching patients to
biosimilars of these biologics led to significant cost savings:
infliximab biosimilars delivered £99.4 million in savings, etanercept
biosimilars delivered £60.3 million, and rituximab biosimilars delivered
£50.4 million, for a cumulative savings of over £220 million in cancer
and autoimmune diseases such as rheumatoid arthritis and inflammatory
bowel diseases.7

Mr. HoUng Kim, Head of Strategy and Operations at Celltrion Healthcare
said, “We have identified clear disparities in access to biologics
across Europe. Patients diagnosed with less than severe disease activity
should be able to get just as good and cost-effective benefit from
biologics as patients with severely active disease, as this will help
them achieve a better quality of life. With the proven savings, gained
through the use of biosimilars, this could be a real opportunity for the
NHS to address these concerning inequalities.”

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Notes to editors:

About rheumatoid arthritis

In Europe, more than 2.9 million people have rheumatoid arthritis (RA),
many of whom are of working age. On average, every third person with RA
becomes work disabled and up to 40 per cent leave work completely within
5 years of diagnosis.8
Although there is no cure for RA,
there are many treatments that can reduce inflammation and ease pain. As
with all rheumatic diseases early diagnosis and intervention is key.

About CT-P13 (biosimilar infliximab)

CT-P13 is developed and manufactured by Celltrion, Inc. and was the
world’s first monoclonal antibody biosimilar approved by the European
Commission (EC). It is indicated for the treatment of eight autoimmune
diseases including rheumatoid arthritis and IBD. It was approved by the
EC under the trade name Remsima®
in September 2013 and
launched in major EU countries in early 2015. The US FDA approved CT-P13
in April 2016 under the trade name Inflectra®
. CT-P13 is
approved in more than 88 countries (as of August 2018) including the US,
Canada, Japan and throughout Europe.

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and
affordable medications to promote patients’ access to advanced
therapies. Its products are manufactured at state-of-the-art mammalian
cell culture facilities, designed and built to comply with the US FDA
cGMP and the EU GMP guidelines. Celltrion Healthcare endeavors to offer
high-quality cost-effective solutions through an extensive global
network that spans more than 120 different countries. For more
information please visit: http://www.celltrionhealthcare.com/